Status:
RECRUITING
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
Lead Sponsor:
argenx
Conditions:
Chronic Inflammatory Demyelinating Polyneuropathy
CIDP
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The main purpose of this study is to compare empasiprubart and IVIg for treating people with CIDP. This study consists of a Part A where participants will either receive empasiprubart and a placebo re...
Eligibility Criteria
Inclusion
- Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
- Has either typical CIDP or 1 of the following CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP
- Has responded to IVIg in the past 5 years
- Receiving treatment with IVIg within a standard optimal maintenance dosing regimen, with a minimum weekly IVIg dose of at least 0.125 g/kg
- Has residual disability and active disease
Exclusion
- Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP or puts the participant at undue risk, including polyneuropathy of other causes
- Meets the criteria for possible or sensory CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
- Use of other long-acting immunomodulatory treatment
Key Trial Info
Start Date :
August 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT06920004
Start Date
August 22 2025
End Date
September 1 2030
Last Update
January 8 2026
Active Locations (10)
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1
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States, 80907
2
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
3
Homestead Associates in Research Inc
Homestead, Florida, United States, 33033
4
Visionary Investigators Network
Miami, Florida, United States, 33133